Comparison of a novel HPV test with the Hybrid Capture II (hcII) and a reference PCR method shows high specificity and positive predictive value for 13 high-risk human papillomavirus infections

Baleriola, Cristina; Millar, Douglas; Melki, John; Coulston, Neralie; Altman, Phillip; Rismanto, Nikolas; Rawlinson, William

doi:10.1016/j.jcv.2007.12.008

« Previous Next »Journal of Clinical Virology
Volume 42, Issue 1 , Pages 22-26, May 2008

Comparison of a novel HPV test with the Hybrid Capture II (hcII) and a reference PCR method shows high specificity and positive predictive value for 13 high-risk human papillomavirus infections

Cristina Baleriola
- Virology Division, Department of Microbiology, South Eastern Area Laboratory Services, Prince of Wales Hospital, Randwick, NSW 2031, Australia
Douglas Millar
- Human Genetic Signatures, Level 4, 11 Julius Ave, North Ryde, NSW 2113, Australia
John Melki
- Human Genetic Signatures, Level 4, 11 Julius Ave, North Ryde, NSW 2113, Australia
Neralie Coulston
- Human Genetic Signatures, Level 4, 11 Julius Ave, North Ryde, NSW 2113, Australia
Phillip Altman
- Altman Biomedical Consulting Pty. Ltd., 152 Cammeray Road, Cammeray, NSW 2062, Australia
Nikolas Rismanto
- Virology Division, Department of Microbiology, South Eastern Area Laboratory Services, Prince of Wales Hospital, Randwick, NSW 2031, Australia
William Rawlinson
- Virology Division, Department of Microbiology, South Eastern Area Laboratory Services, Prince of Wales Hospital, Randwick, NSW 2031, Australia
- Corresponding author. Tel.: +61 2 9382 9113; fax: +61 2 9398 4275.

Received 19 September 2007; received in revised form 15 November 2007; accepted 12 December 2007. published online 13 February 2008.

Abstract

Background

It is well established that human papillomavirus (HPV) infection is highly related to the development of precursor lesions of cervical cancer and uterine cancers. However, for a pre-cancerous lesion to develop, a persistent infection with a high-risk type HPV is necessary.

The Digene Hybrid Capture II (hcII) assay is the only FDA approved method used in conjunction with cytology for HPV screening of women older than 30. The hcII has moderate sensitivity (64.7%) and is dependent on the cellular content of samples, rendering occasionally false positive and false negative results.

Objective

This study aims to evaluate the performance of a new HPV diagnostic kit (High-Risk HPV detection kit, manufactured by Human Genetic Signatures (HGS), Sydney, Australia).

Methods

The method under evaluation was assessed by comparing the results obtained from testing 834 cervical specimens with the HGS method and the Digene hcII method, using genotyping as the reference standard.

Results

Results of the study showed that the specificity and positive predictive value of the HGS High-Risk HPV detection test are significantly greater than those of the Digene hcII test. Overall the HGS HPV assay provides a more accurate system for the detection of high-risk HPV strains, with simpler technical use compared with PCR-sequencing methods.

Keywords: Human papillomavirus (HPV), Cervical cancer, PCR, Diagnostic methods